FDA-Drug2018-03-14Class II
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
Kalchem International, Inc.
Hazard
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Sold states
TX
Affected count
500 gram jar
Manufactured in
224 S Main St Ste B, N/A, Lindsay, OK, United States
Products
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2018Don't want to check this manually?
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